Esomeprazole

The Basics

What is Esomeprazole?

Used to treat the symptoms of gastroesophageal reflux disease (GERD).

Brand names for Esomeprazole

Nexium

How Esomeprazole is classified

Anti-Ulcer Agents, Gastrointestinal Agents, Proton Pump Inhibitors

Esomeprazole During Pregnancy

Esomeprazole pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Esomeprazole while pregnant

There are no adequate and well-controlled studies with NEXIUM in pregnant women. Esomeprazole is the s-isomer of omeprazole. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg (based on a body surface area basis for a 60 kg person). Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age . The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively

Taking Esomeprazole While Breastfeeding

What are recommendations for lactation if you're taking Esomeprazole?

Esomeprazole is the S -enantiomer of the proton-pump inhibitor, omeprazole. Limited information indicates that maternal doses of 20 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants.

Maternal / infant drug levels

Esomeprazole is the S -enantiomer of the proton-pump inhibitor, omeprazole. Limited information indicates that maternal doses of 20 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants.

Possible effects of Esomeprazole on milk supply

Omeprazole (the racemic form) has been reported to cause gynecomastia in men[2] and a retrospective claims database study in the United States found that users of proton pump inhibitors had an increased risk of gynecomastia.[3]

One woman developed elevated serum prolactin and estradiol with bilateral galactorrhea one week after starting esomeprazole 40 mg once daily for reflux esophagitis. The galactorrhea disappeared 3 days after discontinuing esomeprazole and prolactin and estradiol returned to normal 7 days after discontinuation. One month later, the patient restarted esomeprazole and again developed bilateral galactorrhea. She was switched to lansoprazole with no galactorrhea developing.[4] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Possible alternatives to Esomeprazole

Cimetidine, Famotidine, Nizatidine, Omeprazole, Pantoprazole, Ranitidine, Sucralfate.